1) To determine whether vaccination with yellow fever results in a higher cytokine response upon restimulation in vitro with non-related infectious pathogens, compared to the response before the vaccination.2) To determine whether BCG vaccination…
ID
Source
Brief title
Condition
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
According to the objectives:
1) Increase of in vitro cytokine production of PBMCs after stimulation with
different pathogens compared to before yellow fever vaccination. (only placebo
group)
2) Yellow fever antibody titers, Th-immune responses, and proinflammatory
cytokine production in BCG versus placebo vaccinated volunteers.
3) The rate of clearance of the circulating yellow fever vaccine virus in BCG-
versus placebo-vaccinated volunteers.
Secondary outcome
n.v.t.
Background summary
The live attenuated Bacillus Calmette-Guerin (BCG) vaccine protects against
extrapulmonary infection with Mycobacterium tuberculosis and leprosy. It has
been shown that vaccination with BCG, just as other live vaccines as measles,
leads to nonspecific protective effects, e.g. reduced infant mortality as a
result of less severe infections, stimulation of the immune system in patients
with bladder cancer and higher cytokine production upon restimulation of
monocytes with non-related infectious pathogens in vitro. For yellow fever
(YF), which is also a live attenuated vaccine, no immunological confirmation
has been shown yet that it is also able to raise nonspecific protection. Also
whether the BCG vaccine can influence the course of viremia with the yellow
fever vaccine, or boost the yellow fever vaccine, are questions that need to be
answered.
Study objective
1) To determine whether vaccination with yellow fever results in a higher
cytokine response upon restimulation in vitro with non-related infectious
pathogens, compared to the response before the vaccination.
2) To determine whether BCG vaccination can induce a better antibody and
cellular response of the yellow fever vaccine.
3) To determine whether BCG vaccination status has an effect on the clearance
of the yellow fever virus in vivo.
Study design
Explorative randomised placebo controlled trial.
Study burden and risks
There is no known direct benefit for the volunteers to participate in the
trial. The risks are negligible. Vaccination can cause pain and scarring at the
site of injection, just as fever, gastrointestinal symptoms and headache. Local
hematoma formation can occur at the site of the blood drawing. This will be
minimized by the blood collection by experienced persons. Volunteers have to
spend 7 or 8 short visits.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Healthy
18-55 years old
Exclusion criteria
Exposed to TBC, BCG or yellow fever (vaccine), use of mediation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50160.091.14 |